Future of Preventive Services Coverage Under Debate as Court Considers Stay Request

On April 12, 2023, in Braidwood Mgmt., Inc. v. Becerra, No. 20-cv-283 (N.D. Tex.), the federal government asked the district court to partially stay its March 30, 2023, judgment upending aspects of the Affordable Care Act (ACA) preventive services mandate. In that judgment, the court concluded that the Appointments Clause bars enforcement of 42 U.S.C. § 300gg-13(a)(1)'s requirement that health insurers and employer-sponsored health plans cover certain preventive services, and it enjoined the government from implementing or enforcing the preventive services recommendations issued by the U.S. Preventive Services Task Force (PSTF) after passage of the ACA.

The government's partial stay motion seeks a pause on the nationwide impact of the injunction, to the extent that the judgment provides relief beyond the plaintiffs in that case, while the parties appeal the district court's decision to the U.S. Court of Appeals for the Fifth Circuit. The Braidwood plaintiffs opposed the stay request, urging the court to maintain its injunction. The motion is ripe for decision, but the district court does not seem in any hurry to decide it. 

In an order issued April 20, 2023, the district court stated it would defer ruling on the motion and ordered the government defendants to address their assertions that "absent an emergency stay pending appeal, more than 150 million Americans' preventive care services coverage will be disrupted" and to "explain what evidence they have that insureds will lose their [preventive services] coverage." The court referred to a Wall Street Journal article that discussed a letter from six trade groups representing some of the nation's largest employers, health insurers, and health plans, sent to House and Senate Democratic health committee leaders. That letter indicated an overwhelming majority of the groups' members do not anticipate making changes to their health plan coverage for preventive services or cost-sharing for those services while the Braidwood case makes it its way through the courts.

The government responded to the court's April 20 order citing declarations of several government health agency leaders that it claims "demonstrate that an unpredictable number of insurers, employers, and other plan sponsors" will "choose to stop covering the affected preventive services or impose cost-sharing requirements" in the absence of the mandate the Braidwood decision eliminated. The government also claims the trade groups' letter supports its concerns underlying the stay request, because the letter was not based on any scientific surveys and the assertion in the letter that only a "majority" of the groups' members do not anticipate making any coverage changes means that some of them will. The government also highlights that not all entities covered by the ACA mandate were signatories to the letter.

The district court was clearly initially inclined to deny a stay and reminded the parties in its April 20 order that the government can apply for a stay from the Fifth Circuit. Both sides have appealed the district court's March 30, 2023, judgment but no briefs have been filed yet. We anticipate that the parties will end up asking the U.S. Supreme Court to hear the case after the Fifth Circuit rules, given the numerous weighty legal issues in the case, but it is unlikely the case will reach the high court this year. 

Before considering any coverage changes, employers and plans may want to sit tight and await decision on the stay request and outcome of any appeals. Restraint at this juncture could avoid plan design decisions and associated administrative activities that may need to be reversed or modified as the Braidwood case proceeds.

Telehealth Toolkit Published

The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently published a toolkit for "Analyzing Telehealth Claims to Assess Program Integrity Risks." The toolkit provides detailed information on methods to analyze telehealth claims and is based on a methodology that the OIG developed to identify providers whose billing for telehealth services posed a high risk to Medicare due to fraud, waste, and abuse during the first year of the COVID-19 pandemic. The toolkit is intended to assist Medicare Advantage plan sponsors and private health plans, among others, in analyzing their own telehealth claims data to assess program integrity risks. 

Supreme Court Pauses District Court Restrictions on Access to Mifepristone

Late on Friday, April 21, 2023, the Supreme Court granted motions filed by the U.S. Food and Drug Administration (FDA) and Danco Laboratories, LLC to pause an April 7, 2023, order entered by the Northern District of Texas that enjoined the FDA's 2000 approval of the abortion medication mifepristone. The Supreme Court's order stayed the Texas court's decision "pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall terminate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this Court."  As a result of the Supreme Court's order, mifepristone's FDA status and availability are the same as they were before the Texas district court issued its nationwide injunction.

The Supreme Court's brief administrative order noted that Justice Thomas "would deny the application for stay." In a "detached opinion," Justice Alito dissented from the stay grants, criticizing the FDA and dismissing the agency's "regulatory 'chaos' argument."

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